CompletedNot Applicable

A Study of Surgical Interventions in Fistulizing Conditions

United States646 participantsStarted 2021-08-05

Plain-language summary

In this study, participants with complex fistulizing conditions will be treated with surgical interventions according to their clinic's standard practice. The aim of the study is to generate real-world evidence on standard of care for surgical interventions and related outcomes when treating complex fistulizing conditions. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. CPF-CD that meets one or more of the following criteria:
✓. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:
✓. Complex cryptoglandular fistula that meets one or more of the following criteria:
✓. Physician has made the decision to treat with a specific surgical intervention. Procedures may include:

Exclusion criteria

✕. Current participation in interventional clinical trials.
✕. Has CPF-CD: fistula connection to bladder or another organ
✕. Has CCF: diagnosis of Inflammatory Bowel Disease (IBD), including Ulcerative Colitis, and Crohn's Disease (CD).

What they're measuring

Percentage of Participants who Achieve Clinical Remission of Fistula

Timeframe: Baseline up to 24 months

Trial details

NCT IDNCT04940611

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-30

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